Spurious drugs imported from China raises red flag for pharma regulator

New Delhi : Indian government after a few instances of import of spurious and sub-standard drugs from the country were reported, said officials of a regulatory body for pharmaceuticals.

"Active pharmaceutical ingredient (API) estimated to be worth Rs 18,000 crore are imported in India annually and China is the main source of importing drugs in bulk. About 60 per cent of the API comes from China, while the rest comes from Italy, Japan, Europe and the USA.

"Also, it has come to notice that most of the cases of sub-standard drugs, drugs with dubious origin or suspected label are coming from China. To check such infiltration, we have put China on the radar," said an official of the Drug Controller General of India (DGCI) on condition of anonymity.

Clandestine operators push spurious pharmaceutical ingredients labelled under the name of authorised importers which compromise patients' safety, the official said, adding that during checks, it is often found that the drugs are not sourced from the Chinese manufacturers, whose names are referred to in the documents.

Notably, India imports medicines like antibiotics, anti-diabetic, anti-hypertensive, anti-cancer and other regular drugs from several countries and to keep a tab on such imports, the government has put in place an electronic platform ICEGATE to check their quality and authenticity.

Under this programme, the government has framed uniform procedures for sampling and inspection of the drug consignments that come from overseas.

"Through ICEGATE, consignments, bills of entry are electronically placed to the customs which are then scrutinised online by the DGCI port for quality and genuinity. The things which are checked for in imported drugs include documentation, quality, originality of labels etc," said the official.

Drug imports are only allowed from companies whose manufacturing units are registered with the Indian drug regulator.

However, at the domestic front, clandestine operators are much less because regular inspections and sampling of drugs are possible within the country.

DGCI in collaboration with state drug controllers have also launched risk-based inspections all across the country to check the quality of medicine and the manufacturing premises for GMP (Good Manufacturing Practice).

"200 units have been identified on the basis of risks and 105 of them have been inspected. None of them were found to be 100 per cent compliant," the official said.